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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04579302
Other study ID # AP2007-50105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date February 28, 2021

Study information

Verified date March 2021
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.


Description:

90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia: total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients with class II physical status (American Society of Anaesthesiologists) , - Age between 18-70 years, - Scheduled for thoracic cancer surgery Exclusion Criteria: - Patient refusal. - Local infection at the site of the block. - Cardiac dysfunction (ejection fraction <45%). - Significant respiratory disorders. - Preexisting neurological or psychiatric disease. - Allergy to one of the study drugs. - Pregnancy. - Coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Serratus anterior block (SAB)
Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%
Erector spinae block
Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
Drug:
Saline (as a placebo)
Patients will receive a sham block with 20 ml saline (as a placebo)
Bupivacaine
bupivacaine

Locations

Country Name City State
Egypt National Cancer Institute Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary total morphine consumption in first postoperative 24 hours the amount of morphine required to relieve pain will be recorded first 24 postoperative hours
Secondary intraoperative fentanyl requirement the amount of fentanyl required during anaesthesia will be recorded during anaesthesia
Secondary numerical rating scale numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery the first 24 postoperative hours
Secondary pulmonary functions FVC and FEV1 will be recorded at 24 hours after surgery 24 hours after surgery
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